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Background <p>The laryngeal mask airway ( LMA ) is a well-established device for securing the airway, typically inserted using a blind technique. However, blind insertion may result in suboptimal alignment and the need for reinsertion, which can increase the risk of adverse events. Therefore, in this pilot study, we aimed to conduct a preliminary evaluation and gather initial clinical experience with the new video laryngeal mask, SaCoVLM™.</p> Methods and materials <p>In this prospective observational study, the SaCoVLM™ was used for airway management in patients undergoing general anaesthesia. We assessed key quality parameters commonly used to compare the performance of different laryngeal masks. Primary outcome was first attempt success rate. Secondary outcomes were time to achieve adequate ventilation, oropharyngeal leak pressure (OLP), and the incidence of adverse events.</p> Results <p>A total of 50 patients undergoing general anaesthesia were enrolled. The first-attempt insertion success rate was 96%. The mean time to achieve adequate ventilation was 13± 2.4&#xa0;s, and the mean OLP was 38± 3.8 mbar. The overall incidence of adverse events related to video laryngeal mask usage was 6%, with no serious adverse events observed.</p> Conclusion <p>The SaCoVLM™ appears to be a promising alternative for airway management in patients undergoing general anaesthesia, demonstrating favourable performance across key clinical parameters.</p> Trial registration <p>The study was registered in the clinicaltrials.gov on 28th of May 2025 with study registration number NCT07007403 accessible on <a href="https://clinicaltrials.gov/study/NCT07007403">https://clinicaltrials.gov/study/NCT07007403</a>.</p>

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Evaluation of the SaCoVLM, a novel third-generation video laryngeal mask: a prospective observational pilot study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月28日

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  • Michal Kalina,
  • Jan Beneš,
  • Michal Hanauer,
  • Jan Rejholec,
  • Jakub Jobánek,
  • Vladimír Černý

摘要

Background

The laryngeal mask airway ( LMA ) is a well-established device for securing the airway, typically inserted using a blind technique. However, blind insertion may result in suboptimal alignment and the need for reinsertion, which can increase the risk of adverse events. Therefore, in this pilot study, we aimed to conduct a preliminary evaluation and gather initial clinical experience with the new video laryngeal mask, SaCoVLM™.

Methods and materials

In this prospective observational study, the SaCoVLM™ was used for airway management in patients undergoing general anaesthesia. We assessed key quality parameters commonly used to compare the performance of different laryngeal masks. Primary outcome was first attempt success rate. Secondary outcomes were time to achieve adequate ventilation, oropharyngeal leak pressure (OLP), and the incidence of adverse events.

Results

A total of 50 patients undergoing general anaesthesia were enrolled. The first-attempt insertion success rate was 96%. The mean time to achieve adequate ventilation was 13± 2.4 s, and the mean OLP was 38± 3.8 mbar. The overall incidence of adverse events related to video laryngeal mask usage was 6%, with no serious adverse events observed.

Conclusion

The SaCoVLM™ appears to be a promising alternative for airway management in patients undergoing general anaesthesia, demonstrating favourable performance across key clinical parameters.

Trial registration

The study was registered in the clinicaltrials.gov on 28th of May 2025 with study registration number NCT07007403 accessible on https://clinicaltrials.gov/study/NCT07007403.